The controversy over the use of paclitaxel-bearing devices in the femoropopliteal arteries is far from over. Now, a new medical journal article makes a similar claim about mortality in connection with the use of these devices in the infrapopliteal arteries, threatening once again to take a bite out of utilization.

Ra Medical Systems Inc., of Carlsbad, Calif., reported that the U.S. FDA has granted investigational device exemption (IDE) approval to study its DABRA excimer laser system as an atherectomy device to treat peripheral vascular stenosis.

Dublin-based Medtronic plc has snagged the U.S. FDA’s approval for its Micra AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. The company said it will begin rolling out the device at a limited number of medical centers in the upcoming weeks, with a full, nationwide launch sometime this spring. About the size of a large vitamin pill, the leadless Micra AV is indicated for the treatment of patients with AV block, a disorder that occurs when the electrical signal traveling from the atria, or upper chambers of the heart, to the ventricles, or lower chambers, is impaired.

Novo Nordisk A/S' Ozempic, a once-weekly injectable version of the company's glucagon-like peptide-1 (GLP-1) receptor agonist, semaglutide, first FDA-approved in late 2017, has won the agency' approval for a new indication: reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (T2D) and known heart disease.

A new study of 30 patients has demonstrated that embolization coils adequately seal the left atrial appendage after implant of LAA closure devices, but the author of an accompanying editorial expressed concerns regarding the absence of understanding of both the causes and implications of these leaks.

Device makers only can watch when cardiologists grapple with federal agency officials over device utilization. However, cardiologists are punching back hard against a rule used to judge whether a coronary artery stent is appropriately used, thus ensuring these devices won’t suffer a significant drop in utilization.